Regulatory affairs lead

Serova•London, California

2d•Onsite

About The Position

Serova builds personalized cancer vaccines. Each vaccine is made for the individual patient from their own samples and given in partnership with their treating physician. We work with the FDA to get patients access through expanded access today, and we're building toward trials. You'll own regulatory strategy and execution for our therapeutics: the cancer vaccine program and our personalized therapies. That's the core of the job. We also run sequencing and tests, so diagnostics experience would be useful too.

Requirements

Regulatory experience with the FDA on INDs, biologics or early clinical development
You've drafted and driven submissions personally, not only managed them
Based in the San Francisco Bay Area or London, or willing to relocate
Authorized to work in the US or UK, or a realistic path to get there

Nice To Haves

Expanded access and single-patient INDs, including running many concurrent cases
Diagnostics regulation: research-use versus CLIA requirements, or taking a test to market
Multi-country experience: MHRA, EMA and Australia's TGA as well as the FDA
Oncology, personalized or advanced therapies
CMC and GMP knowledge for IND submissions
FDA expedited programs: Fast Track, Breakthrough Therapy, Accelerated Approval
Import and export rules across regions

Responsibilities

Set regulatory strategy for our therapeutics: the cancer vaccine program and our personalized therapies
Support regulatory work on our diagnostics: our sequencing work, research-use versus CLIA requirements, and any test we take to market
Run expanded access submissions end to end across many concurrent cases: drafting single-patient INDs, FDA interactions, amendments and follow-ups
Coordinate the clinical, CMC, nonclinical and safety inputs to each submission
Build the roadmap from single-patient INDs to scalable expanded access, and then a Phase 1 trial
Own our relationships with the FDA, MHRA and other regulators, and trial submissions
Handle import and export across regions, and pick the right route for each case (expanded access or a trial)
Work with quality and manufacturing where CMC and GMP feed into submissions
Review patient-facing materials and advise our Bozeman clinic
Build out the regulatory function, including external advisors